Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

NCT05824065 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: OMA102-III-0123
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.

Conditions

Female Pattern Baldness

Outcome Measures

Primary Outcomes (1)

• Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.

  Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.

  6 months

Secondary Outcomes (5)

• Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.

  3 months

• Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of non vellus and vellus hair growth, in the mid frontal area, assessed by digital phototrichogram.

  3 and 6 months

• Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception.

  3 and 6 months

• Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Patient Global Impression, PGI-I, by the subject perception.

  3 and 6 months

• Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL).

  3 and 6 months

Study Arms (3)

OMA102 1 mg

EXPERIMENTAL

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Drug: OMA102

OMA102 2 mg

EXPERIMENTAL

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Drug: OMA102

Placebo

PLACEBO COMPARATOR

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Drug: Placebo

Interventions

OMA102 DRUG

1 mg

OMA102 1 mg

Placebo DRUG

OMA102 - Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Age greater than 18 and equal or under 50 years;
• Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;
• Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.

You may not qualify if:

• Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study
• History of alcohol or illicit drugs abuse in the last year;
• Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;
• Allergy or sensibility to any knowing components of the formula;
• Diagnosis of arterial hypertension;
• History of vasovagal syncope;
• Baseline systolic blood pressure lower than 90 mmHg and/or diastolic lower than 60 mmHg;
• Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and/or diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);
• Body mass index (BMI) \> 30 kg/m²;
• History of cardiovascular, liver and renal diseases;
• History of hypothyroidism, hyperthyroidism or pheochromocytoma;
• Signs or symptoms of cardiopathy or angina;
• History of edema from any etiology;
• Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;
• Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

EMS

Hortolândia, São Paulo, Brazil

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cassiano Ricardo O Berto, B.S.

CONTACT

+551938877724; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 21, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 16, 2024

Record last verified: 2023-04

Locations

BR (1)